The Dutch chronic lower limb-threatening ischemia registry (THRILLER): A study protocol for popliteal and infrapopliteal endovascular interventions

Introduction Chronic limb-threatening ischemia (CLTI) is the end stage of peripheral arterial disease (PAD) and is associated with high amputation rates, mortality and disease-related health care costs. In infrapopliteal arterial disease (IPAD), endovascular revascularization should be considered for the majority of anatomical and clinical subgroups of CLTI. However, a gap of high-quality evidence exists in this field. The aim of the Dutch Chronic Lower Limb-Threatening Ischemia Registry (THRILLER) is to collect real world data on popliteal and infrapopliteal endovascular interventions. Method... Mehr ...

Verfasser: Nugteren, Michael J.
Hazenberg, Constantijn E. V. B.
Akkersdijk, George P.
Bakker, Olaf J.
Dinkelman, Maarten K.
Fioole, Bram
van den Heuvel, Daniel A. F.
Heyligers, Jan M. M.
Hinnen, Jan-Willem
Pierie, Maurice
Schouten, Olaf
Schreve, Michiel A.
Verhoeven, Bart A. N.
de Borst, Gert J.
Ünlü, Çağdaş
Dokumenttyp: Artikel
Erscheinungsdatum: 2023
Reihe/Periodikum: PLOS ONE ; volume 18, issue 7, page e0288912 ; ISSN 1932-6203
Verlag/Hrsg.: Public Library of Science (PLoS)
Sprache: Englisch
Permalink: https://search.fid-benelux.de/Record/base-29028662
Datenquelle: BASE; Originalkatalog
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Link(s) : http://dx.doi.org/10.1371/journal.pone.0288912

Introduction Chronic limb-threatening ischemia (CLTI) is the end stage of peripheral arterial disease (PAD) and is associated with high amputation rates, mortality and disease-related health care costs. In infrapopliteal arterial disease (IPAD), endovascular revascularization should be considered for the majority of anatomical and clinical subgroups of CLTI. However, a gap of high-quality evidence exists in this field. The aim of the Dutch Chronic Lower Limb-Threatening Ischemia Registry (THRILLER) is to collect real world data on popliteal and infrapopliteal endovascular interventions. Methods THRILLER is a clinician-driven, prospective, multicenter, observational registry including all consecutive patients that undergo a popliteal or infrapopliteal endovascular intervention in seven Dutch hospitals. We estimate that THRILLER will include 400–500 interventions annually. Standardized follow-up visits with wound monitoring, toe pressure measurement and duplex ultrasonography will be scheduled at 6–8 weeks and 12 months after the intervention. The independent primary endpoints are primary patency, limb salvage and amputation free survival. Patients must give informed consent before participation and will be included according to predefined reporting standards. A data log of patients who meet the inclusion criteria but are not included in the registry will be maintained. We intend to conduct the first interim analysis two years after the start of inclusion. The results will be published in a scientific journal. Discussion Despite innovations in medical therapy and revascularization techniques, patients with CLTI undergoing endovascular revascularization still have a moderate prognosis. Previous prospective cohort studies were hampered by small sample sizes or heterogeneous reporting. Randomized controlled trials (RCTs) have high costs, potential conflicts of interest and give a limited reflection of daily practice. THRILLER aims to provide the largest prospective well phenotyped up-to-date dataset on treatment ...